Events

Alerte De Sécurité sur Mass Spectrometry Instruments

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Waters Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-10-24
  • Date de publication de l'événement
    2012-10-24
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121024a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: waters corporation mass spectrometry instruments medical device manufacturer, waters corporation, has initiated a medical device field safety corrective action concerning various models of mass spectrometry instruments. the affected models can be identified as follows:- waters acquity tqd; acquity sqd; lct premier xe; quattro premier; quattro premier xe; quattro micro; xevo g2 tof; xevo tq; xevo tqd & zq 2000 the manufacturer initiated this voluntary medical device correction because there is a possibility that the ion block source heater may fail. in some instances, the failure could cause a short term loss of or variation in sensitivity that may subsequently lead to inaccurate data. the loss of or variation in sensitivity is most pronounced in assays with shorter dwell times (i.E. less than 100 ms) and may not always be detected by quality control and internal standard value monitoring. no adverse events have been reported as a result of this potential issue. according to the manufacturer, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 october 2012.

Device

Mass Spectrometry Instruments
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Waters Corporation Mass Spectrometry Instruments
  • Manufacturer
    Waters Corporation

Manufacturer

Waters Corporation